Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT07321379
Starting soon Not applicable

Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour

NCT07321379 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Hvidovre
Phase
Not applicable
Started
2026-02-01
Last updated
2026-01-12

Condition(s) studied

Prolonged LaborLabor Dystocia

Investigational drug(s) / intervention(s)

Sodium bicarbonate →Placebo

Sodium bicarbonate: 4,26 gram given once.

Placebo: Placebo given once.

Study summary

The goal of this clinical trial is to learn if oral bicarbonate can treat prolonged labour in nulliparous women with prolonged labour.

The main question it aims to answer is: Do oral bicarbonate and restrictive oxytocin use reduce assisted delivery rate (emergency cesarean and vacuum/forceps delivery) in nulliparous women with prolonged labour.

Researchers will compare bicarbonate and placebo (a look-alike substance that contains no drug) to see if bicarbonate works to treat prolonged labour.

Participants will:

* drink bicarbonate or placebo
* have cervical dilatation reassessed after 2 hours. If still slow progression, they will follow standard protocol for oxytocin augmentation
* will receive a questionnaire 1 month post partum to assess birth experience

1/3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years. * Danish or English speaking. * Cephalic presentation. * Gestational age ≥34+0 - \<42+0 (days +weeks) at onset of labour. * Normal foetal heart rate pattern in the 20 minutes prior to inclusion. * Spontaneous onset of labour or non-medical induced labour (balloon catheter and/or artificial rupture of membranes). * Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - \<10 cm with regular painful contractions. * Prolonged labour diagnosed, according to Danish national guidelines: Cervical dilatation progresses at less than 2 cm over a 4-hour period. Exclusion Criteria: * Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated) * Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis. * Serious obstetric complication * Known allergy or intolerance to sodium bicarbonate. * Ingestion of sodium bicarbonate in active labour prior to inclusion. * Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)

Primary outcome measure(s)

  • Difference in incidence of assisted delivery — At birth
    Defined as a composite of emergency caesarean section and instrumental vaginal delivery

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark
Copenhagen University Hospital, Hvidovre Copenhagen Denmark
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark

More Copenhagen University Hospital, Hvidovre trials in Denmark

Virus as Treatment of C. Difficile Infection (VISION) Starting soon
Intraoperative Perfusion Index and Mortality Active, not recruiting
The Effect of Anti-IL17 on Airway Hyperresponsiveness and Resistance Recruiting
GRACE - Graduated Response for Advanced COPD With Enhanced Support Recruiting
Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321379 on ClinicalTrials.gov ↗ ← All trials in Denmark